Agreements among
accreditation bodies
Dr. Rózsa Ring
Director of the Hungarian
H ngarian Accreditation Board
Executive Committee member and Treasurer of EA
Serving the European Economy and Society
Contents
What is the EA MLA?
EA MLA – structure & peer evaluation
EA MLA/BLA signatories
ILAC MRA & IAF MLA 1
EA MLA (1)

The EA MLA is an agreement signed between the
EA accreditation body members to recognise the
equivalence,
i l
reliability
li bili and
d therefore
h f
acceptance off
accredited certificates, inspection reports,
calibration certificates and test reports across
Europe.

The MLA eliminates the need for suppliers of
products
d t or services
i
to
t be
b certified
tifi d in
i each
h country
t
where they sell their products or services, and
therefore provides a means for goods and services
to cross boundaries in Europe and throughout the
world.
EA MLA (2)

It delivers confidence in the service supplied by
accredited laboratories, inspection and
certification bodies, thereby providing the
framework for goods and services to cross
borders in Europe and throughout the world,
acting as a "passport for trade".

The National Accreditation Body's mark on
test reports and certificates is the assurance of
the benefits of the MLA.
2
EA MLA (3)
The EA Multilateral Agreement accepts:
 the
th equivalence
i l
off the
th operation
ti off the
th
accreditation systems administered by
EA MLA signatory members;
 that the certificates and reports issued by
g
accredited by
y EA MLA
organisations
signatory members are equally reliable.
EA MLA (4)
Benefits for governments and regulators (1)


Flexibility of approach: accreditation delivers a multi-discipline
solution that can be applied to support or act as an alternative to
legislation (765/2008/EC Regulation; 768/2008/EC Decision); Increased
confidence in data that is used to establish baselines for
monitoring and enforcement;
Trade facilitation due to internationally accepted testing and
measurement practices, data generated by an accredited
laboratory may lead to the more ready acceptance of exported
goods in overseas markets. This reduces costs and eases exports
and imports, as it reduces or eliminates the need for retesting in
another country;
3
EA MLA (5)
Benefits for governments and regulators (2)


Efficient Government: Accreditation delivers a balance
between risk and protection as it reduces the need for
government and regulators to carry out additional
audits, and so employ additional inspection staff;
Create a competitive environment: businesses are able
to differentiate their products and services, as well as
being able to exploit overseas opportunities opened up
through the mutual recognition arrangements.
EA MLA (6)
Benefits for industry and business community (1)


Accreditation saves business time and money as it removes the
need to re-test or re-certify a product in each and every
country where it is sold.
The EA MLA is a European network that supports industry
and trade by removing barriers to trade: an accredited test
performed in one country is recognised in all the other MLA
signatory countries. For the manufacturer or the importer, it
ensures greater access to new growth areas, and speed to
market.
4
EA MLA (7)
Benefits for industry and business community (2)
How to ensure that a certificate or test report is acceptable?





check that there is an accreditation mark on the report or
certificate;
check that the accreditation mark is a mark of an accreditation
body signatory to the EA MLA (ILAC MRA or IAF MLA);
check that the supplier is accredited for the competence, the tests,
the results you need;
check that the tests have been carried out against international
standards. Alternatively, check that the standards, methods used
can be accepted in the country of destination;
in case of problems, contact the national accreditation body.
EA MLA (8)
Benefits for European citizens (1)


The EA MLA benefits all European citizens as accreditation
underpins the quality of the air we breathe, the safety of the
food we eat, the safety of our working environment.
As an example, there is an ongoing project to develop
accreditation for the certification of services performed by the
breast cancer units (diagnosis, treatment) throughout Europe.
It is a clear expectation of the European Parliament to make
the same high quality services available to all women in
Europe.
5
EA MLA (9)
Benefits for European citizens (2)
Accreditation:
• Delivers Public Confidence: Despite a complex global
marketplace, accreditation gives us confidence through
ensuring consistently high standards in the quality of
products or services purchased.
• Minimises product failure or recalls: Product testing carried
out by a reliable independent organisation will minimise
products failing
p
g or p
potential recalls.
• Prevents dangerous outbreaks: Tests conducted by accredited
laboratories will prevent the risk of outbreaks (from food
poisoning to water contamination) that can be hazardous to
the public.
EA MLA (10)
Article 11 of 765/2008/EC Regulation
Presumption of conformity for national accreditation
bodies
1. National accreditation bodies that demonstrate conformity with the
criteria laid down in the relevant harmonised standard, the
reference of which has been published in the Official Journal of
the European Union, by having successfully undergone peer
evaluation under Article 10 shall be presumed to fulfil the
requirements laid down in Article 8.
2. National authorities shall recognise
g
the equivalence
q
of the services
delivered by those accreditation bodies which have successfully
undergone peer evaluation under Article 10, and thereby accept,
on the basis of the presumption referred to in paragraph 1 of this
Article, the accreditation certificates of those bodies and the
attestations issued by the conformity assessment bodies accredited
by them.
6
EA MLA (11)
Article 23 of 768/2008/EC Decision
Notification procedure
4.. Where a notification is not based on an accreditation certificate, the
notifying authority shall provide the Commission and the other
Member States with documentary evidence which attests to the
conformity assessment body's competence and the arrangements
in place to ensure that that body will be monitored regularly and
will continue to satisfy the requirements.
requirements.
5. The body concerned may perform the activities of a notified body
only where no objections are raised by the Commission or the
other Member States within two weeks of a notification where an
accreditation certificate is used or within two months of a
notification where accreditation is not used.
used.
EA Multilateral Agreement
June 2007 Rev 5
7
EA--1/06 (1)
EA
1.
2.
3.
The Agreement is based on the results of the
evaluations carried out in accordance with the EA
p
procedure.
The parties entering the Agreement are the
Accreditation Bodies in each country on behalf of
which the Agreement was signed.
EA MLA members shall not in any way market or
promote their accreditation services in another EA
Member country. This will not prevent an AB from
providing accreditation services if requested by a
CAB or AB, taking into account the principles of the
Cross Frontier Policy.
EA--1/06 (2)
EA
4.
On the basis of the equivalence of the operation of
the Schemes operated by the Signatories and hereby
declared each Signatory to this Agreement will:
declared,
i.
ii.
iii.
accept the other Schemes operated by the other
Signatories as equivalent to its own Scheme(s);
recognise as being equally reliable the certificates and/or
reports from the organisations accredited by the
Signatories under their equivalent Schemes;
recommend and promote the acceptance of certificates
and/or reports from the organisations accredited by the
Signatories under their Scheme(s) by all users in
countries of the Signatories;
8
EA--1/06 (3)
EA
On the basis of the equivalence of the operation of the Schemes
operated by the Signatories and hereby declared, each
Signatory
g
y to this Agreement
g
will:
iv. investigate all complaints initiated by a Signatory
resulting from certificates and/or reports issued by an
accredited organisation of its own Scheme(s);
v. notify all other Signatories and the MLA secretariat as
soon as possible of any significant changes that have
occurred or will occur in its status or in the operational
practices of its Scheme(s);
vi. nominate and commit itself to providing a number of peer
evaluators in proportion to its size and to the needs of the
MLA Council;
EA--1/06 (4)
EA
On the basis of the equivalence of the operation of the Schemes
operated by the Signatories and hereby declared, each
Signatory to this Agreement will:
vii. operate according to the criteria specified in the relevant
European Standards, published in the ISO/IEC 17000
and EN 45000 series of standards, or other
internationally recognised normative documents,
supplemented by EA application documents, if
necessary;
viii. commit its evaluators to participate in training and
retraining as appropriate.
9
EA--1/06 (5)
EA
5. An EA member may refer at any time to its signatory status
of the MLA. If the member is not a signatory
g
y to all MLA
schemes, it shall specify to which MLA it is signatory.
6. If, in accordance with the procedures set out in EA
documentation, it is agreed that a further Accreditation Body
will participate in the Agreement covering the scheme, a new
signature sheet shall be signed by the new Accreditation
Body and duly authorized by the Chairman of the MLA
Council The new Signatory shall be added to EA
Council.
EA-1/08
1/08 and
the list of MLA signatories available on the EA website. An
analogous rule shall apply if it is agreed that a Signatory may
extend its Scheme(s).
EA--1/06 (6)
EA
7.
8
8.
If a Signatory, for any reason whatsoever, has to withdraw
from this Agreement or to reduce the extent of its Scheme(s),
Scheme(s)
the other Signatories shall be notified in writing not later
than three months in advance of withdrawing or reducing.
Upon withdrawal of a Signatory or reducing the extent of its
Scheme(s), EA-1/08 and the list available on the EA website
shall be amended accordingly.
This Agreement supersedes any previous Multilateral
Agreement, which may exist between the Signatories.
10
EA--1/06 (7)
EA
9.
Any amendment of the text of this Agreement shall be made
in accordance with the rules of procedure established by EA.
EA
10. In the event of an appeal the matter shall be dealt with in
accordance with EA-2/01-S3 EA Procedure for the
Investigation and Resolution of Complaints & Appeals.
11. It is recognised and accepted by each of the Signatories that
this Agreement does not create any rights, liabilities or
obligations
bli ti
that
th t would
ld have
h
binding
bi di effect
ff t in
i national,
ti
l
international or European Community law.
Contents
What is the EA MLA?
EA MLA – structure & peer evaluation EA MLA/BLA signatories
ILAC MRA & IAF MLA
11
Structure of EA MLA (1)
New structure
five tiers
Tier 1: ISO/IEC 17011
Tier 2: accreditation activity (scope) in which the AB
has demonstrated competence (like testing;
calibration; certification of products, management
systems, persons; inspection)
Tier 3: generic standards or normative documents
used by the AB to assess the CAB technical
competence for each accreditation activity (like
ISO/IEC 17025, 17020, 17021, 17024, ISO 15189, EN
45011)
Structure of EA MLA (2)
Tier 4: sector specific standards or normative documents
used in combination with one of the generic standards
of tier 3 (like ISO/TS 22003, ISO/IEC 27006 or
schemes like WADA)
Tier 5: standards or normative documents used by the
accredited CAB to deliver an accredited conformity
assessment service, like test methods or standards at
the laboratories, ISO 9001 or other management
systems standards, product specification or standards,
national or international schemes or normative
documents issued by the regulators.
12
Structure of EA MLA (3)
New accreditation activities in the MLA
Whenever a new standard or normative document
used for accreditation comes to the market, the
EA General Assembly will decide whether it
should be classified under the MLA and by what
mechanism; a new accreditation activity (Tier 2)
or a new normative document under one of the
endorsed accreditation activities (Tier 3).
Structure of EA MLA (4)
New sector specific schemes in the MLA
The criteria and the process for accepting a
new sector specific scheme into the list of
endorsed EA sector specific schemes
(Tier 4) are given in EA-2/11 EA Policy
for Sector Schemes.
13
Scopes of EA MLA
Accreditation of
laboratories
Testing,
g, calibration
medical analysis
EN ISO/IEC 17025
ISO 15189
Accreditation of
certification bodies
Certification of
poducts
EN 45011
Certification of
management systems
EN ISO/IEC 17021
C ifi i off
Certification
persons
EN ISO/IEC
SO/ C 17024
1 024
Inspection
EN ISO/IEC 17020
Accreditation of
inspection bodies
(ISO/IEC Guide 65)
Other activities of the EA member ABs
Accreditation not covered by EA MLA
EMAS verifiers - FALB
GHG verifiers
PT providers
RM producers
Attestors for public procurement
Good Laboratory Practise
14
Management of the EA MLA



The strength of the EA MLA is maintained through a
robust peer evaluation process. The purpose of these
rigorous
i
on-site
i evaluations
l i
is
i to verify
if the
h Accreditation
A
di i
Body signatories' continuing conformity with the
internationally accepted criteria.
ABs are evaluated against the international standard
ISO/IEC 17011, other related criteria such as
application documents from EA, ILAC or IAF and
applicable criteria on behalf of European or national
regulators and industrial schemes.
The MLA process is overseen by the European
Commission, the EA Advisory Board and the national
authorities.
EA Policy and Procedures for the
Multilateral Agreement
No ember 2008 Rev
November
Re 05
Effective from 18 January 2009
15
EA--2/02 (1)
EA


The document describes the procedures that EA has
adopted for the evaluation and re-evaluation of
nationally recognised ABs,
ABs the operation of their
accreditation systems and their accredited
organisations when these ABs are or wish to be
signatories to EA Multilateral Agreement or wish to
enter into mutual recognition with an EA
Multilateral Agreement as an individual AB.
Th procedure
The
d
iis ffully
ll based
b d on th
the common
ILAC/IAF document for the evaluation of single
ABs.
EA--2/02 (2)
EA
Criteria (1)


ISO/IEC 17000 series of standards and other
ISO/IEC guides
ILAC, IAF, EA guides mandatory for the EA
MLA
Applicant ABs and signatories shall bring these guidance
d
documents
t tto th
the attention
tt ti off th
the accredited
dit d organisations
i ti
for their use as accreditation criteria supporting the
requirements in the accreditation standards.
16
EA--2/02 (3)
EA
Criteria (2)
 Supplementary requirements, the AB
 shall
h ll be
b ffully
ll operational;
i
l
 shall have sufficient experience in the assessment of its
accredited organisations and have carried out at least one
accreditation in each of the certification accreditation
programs and inspection program for which it applies,
for laboratory accreditation in the testing field at least
four accreditations and for laboratory accreditation in the
calibration field at least four accreditations;
 shall implement or fulfil other requirements of EA as
described in the documents listed in EA-1/01 in
accordance with the document categories described in
EA-2/12.
EA--2/02 (4)
EA
Criteria (3)
 Proficiency
Testing and other Laboratory Comparisons
The AB shall
Th
h ll demonstrate
d
t t that
th t it has
h an effective
ff ti policy
li in
i
place in accordance with ISO/IEC 17011 and ILAC/EA
mandatory documents to ensure appropriate participation by
its accredited bodies in PT and other laboratory comparison
activities. The AB shall ensure that accredited bodies
implement appropriate corrective action where necessary.
Every applicant AB or Signatory to the MLA in the fields of
calibration
lib ti and
d testing
t ti shall
h ll ensure its
it laboratories
l b t i
participate in regional or national PTs and other laboratory
comparisons where available and appropriate. ABs shall
ensure that the results of the regional activities are reviewed
and appropriate corrective action taken as necessary.
17
EA--2/02 (5)
EA
Criteria (4)
Subcontracting
g
The Accreditation Body (AB) can only subcontract
assessment activities to ABs having signed the MLA for
that particular activity (IAF/ILAC or an MLA from a
recognised region).
Types of peer evaluation
 Pre-evaluation
 Full
(initial) evaluation
 Re-evaluation
2 years after the initial evaluation, 4 years between the reevaluations, the duration of a re-evaluation is comparable to
that of an initial evaluation.
 Extraordinary
evaluations
The duration and the tasks of the extraordinary evaluations are
basically determined by the EA MAC.
18
Contents
What is EA MLA?
EA MLA – structure & peer evaluation
EA MLA/BLA signatories
ILAC MRA & IAF MLA
EA MLA/BLA signatories (1)
Scopes
Testing
Calibration
Inspection
Product certification
QMS certification
EMS certification
Persons certification
MLA
28
26
27
27
27
27
24
BLA
7
7
4
1
2
2
19
EA & MLA Members
April 2010
Calibration ; testing ; products, quality
management systems and persons
certification ; inspection
New signatories for full scope
Calibration ; testing ; products, quality
management systems and persons
certification
Calibration ; testing ; products and quality
management systems certification; inspection
Calibration; testing; products
and quality management
systems certification
Persons and quality management
system certification
Environnemental management
systems certification
Calibration ; testing
Full members non
signatories
Contracts of Cooperation (European countries)
EA MLA Signatories April 2010
Austria
Belgium
Bulgaria
France
Germany
Greece
Malta
Netherlands
Norway
Slovenia
Spain
Sweden
Czech Rep.
Ireland
Poland
Switzerland
Denmark
Italy
Portugal
Turkey
Estonia
Latvia
Romania
Finland
Lithuania
Slovakia
United Kingdom
Hungary
Croatia
20
Signing the EA MLA
Zürich, 20 May 2010
HAA
NAT
EA BLA Signatories








Australia
Israel
New Zealand
Russia
South Africa
Singapore
Ukraine
Tunisia
21
Contents
What is EA MLA?
EA MLA – structure & peer evaluation
EA MLA/BLA signatories
ILAC MRA & IAF MLA
ILAC Mutual Recognition
Arrangement
2007 Rev
Re 4
22
ILAC MRA signatories (1)
 Testing
Testing::
EA, APLAC, IAAC & 63 ABs
 Calibration
Calibration::
 Inspection
Inspection::
EA, APLAC, IAAC & 55 ABs
in progress
ILAC MRA signatories (2)












Argentina
Australia
Brazil
Canada (2)
China
Costa Rica
Cuba
Egypt
Guatemala
Hong Kong
India
Indonesia












Israel
Japan (3)
Korea
Malaysia
Mexico
New Zealand
Pakistan
Papua New Guinea
Philippines
Russian Federation
Singapore
South Africa







Sri Lanka
Taiwan
Thailand (3)
Tunesia
United Arab Emirates
USA (7)
Vietnam
EA MLA
23
IAF Multilateral Recognition
Agreement
22 January
Jan ar 1998
IAF MLA signatories (1)
 QMS
certification:
certification: EA, PAC, IAAC & 41 ABs
 EMS
certification:
certification: EA, PAC & 37 ABs
 Product
certification:
certification: EA, PAC & 33 ABs
24
IAF MLA signatories (2)












Argentina
Australia
Brazil
Canada
China
Egypt
Guatemala
Hong Kong
India
Indonesia
Japan
Korea (2)

Malaysia
Mexico
New Zealand
Philippines
Singapore
South Africa
Taiwan
Thailand
Tunesia
USA (2)
Vietnam

EA MLA










International co
co--operations in the region
DA
BATA
HAA
KAD
IARM
ATCG
ATS
EA
Associate
Associate
Full
Associate
Full
Associate
Associate
ILAC
Associate
Associate
Associate
Applied
for
Associate
Associate
Associate
Associate
IAF
AB
-
-
-
-
-
-
EA
MLA
Applied
for testing
Applied
for testing,
testing,
calibration
inspection
Signatory
for full
scope 28
April 2010
-
Pre
Pre-evaluation
for testing,
inspection,,
inspection
product CB
-
Pre
Pre-evaluation
for testing,
calibration
inspection
25
Finally

The international accreditation network is growing as more
economies have set up competent national Accreditation
Bodies. Since 2003, the number of new established
Accreditation Bodies has grown by 42% globally.
globally In Europe
Europe,
all Member States and the candidate countries have
established a national Accreditation Body.

The number of accredited bodies in Europe has increased
significantly in the last five years. Today, there are more than
20 500 bodies accredited by EA MLA signatories, compared
to 14 000 in 2004,, representing
p
g ggrowth of 46%. At the
international level, there are almost 30 000 laboratories
accredited by ILAC MRA signatories, representing the same
growth rate since 2004.
Thank you for your kind
attention!
Questions?
26